Free Speech for Pharmaceutical Companies!

According to the FiercePharma blog, the U.S. Food & Drug Administration is unlikely to deliver new guidelines for pharmaceutical companies to use digital and social media in marketing and education efforts by its own long overdue deadline. Meanwhile, pharmaceutical companies remain understandably nervous about actively engaging with patients online, with a recent Deloitte study indicating that 35 percent have no interest in social media, with more than half citing a lack of clarity about what it permissible as a major obstacle to improved engagement with their customers.
If I could have just one wish for 2011, it would be for a serious rethink of the way healthcare regulators around the world regulate the interactive between pharmaceutical companies and the public. (Okay, that’s a lie; there are lots of things I would wish for first. But such a rethink is so long overdue I’m prone to hyperbole when I think about it.)
Any approach to regulating the dialogue between pharmaceutical companies and their customers should be based on several key principles.
First, that more information is a good thing. Today’s regulations seem to be based in a 50-year old way of thinking that viewed patients are passive recipients in their own healthcare. They should reflect the reality of the modern age, which is that patients have a right to be active participants in decisions regarding their own health. They should have access to all and any information that makes such participation easier. Helping them gain that access is in their interest and the public interest.
Second, the information environment should be designed to benefit responsible adults. Yes, there ought to be a balance between protecting the vulnerable and providing useful information to the smart and sophisticated. But that balance is tilted too far in the direction of the former. It’s lowest common denominator regulation: “Don’t say anything that we can even imagine the most dense consumer might possibly misunderstand”).
Third, any areas of uncertainty should be discussed and debated openly. Today, in most markets, we live in a world of black and white. If something has been approved by the appropriate regulator, it can be discussed. If not, the company must remain silent. But there are grey areas: disagreement about risks and side-effects, therapeutic categories in which drugs show promise even though they have not yet been approved. Companies ought to be able to enter into adult discussions with their consumers about these areas
Fourth, regulators should pay attention to misleading claims that come from any source. Today, companies are swiftly punished for any misleading claim (or even perfectly accurate claims that are not FDA approved); but critics can say almost anything about a pharmaceutical product. At the very least companies should be able to respond to these claims, but ideally regulators should be prepared to call out criticisms that have no grounding in scientific reality. (I’m not suggesting regulators should have the power to fine industry critics, but they should be more vocal in “refereeing” disputes.)
Fifth, any deception or dishonesty should be punished severely. Companies need to understand that a more open communications environment is not a license for them to exaggerate or mislead. When companies do cross the line, they should be punished much more severely than they are today. That’s a small price to pay for greater freedom of speech.